Method for sterilizing a medical device having a hydrophilic coating

a technology of hydrophilic coating and medical device, which is applied in the direction of catheters, nuclear engineering, therapy, etc., can solve the problems of osmotic potential, risk of coating abrasion during insertion, water will be extracted from the hydrophilic surface coating and into the tissues of the surrounding mucous membrane, etc., to achieve the effect of reducing friction force and prolonging water draining tim

Inactive Publication Date: 2006-01-17
COLOPLAST AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0021]The invention further relates to a medical device comprising a hydrophilic coating said medical device showing, after sterilization using radiation, a prolonged water drain off time and a reduced friction force.

Problems solved by technology

Whereas such coating is not particularly smooth when dry, so that the handling of the device may become inconvenient, it becomes extremely slippery when it is swelled with water, preferably immediately before introduction into the human body and thus ensures a substantially painless introduction with a minimum of damage on tissue.
When the product remains inside the body only for a short period, there may be a risk that water will be extracted from the hydrophilic surface coating and into the tissues of the surrounding mucous membranes etc., owing to a higher osmotic potential of said tissues.
At the same time, there is a risk of abrasion of the coating during insertion.
As a result of the extraction of water or loss of coating, the hydrophilic surface coating will have a tendency to become less slippery and to stick to surrounding tissues, and the removal of the medical device from the body may cause pain or damage the tissue.
This is especially a problem when carrying out urodynamic examinations via a catheter.
It has been found, however, that most hydrophilic coatings lose their water retention and that the coefficient of friction increase when the coatings are stored in water for an extended period of time and / or particulary after sterilisation using irradiation or autoclaving.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0088]Preparation of a catheter having a crosslinked two-layer hydrophilic coating.

[0089]5 parts of PVP K 90 and 0.05 part of ESACURE KIP 150 were dissolved in 94.95 parts of an ethanol / gamma butyrolactone solvent mixture. PVC-catheters were dipped in the solution and dried 1 minute at ambient temperature and then dipped in a PVP-solution containing 5 parts of PVP, 1 part of urea and 94 parts of an ethanol / gamma butyrolactone (85 / 15) solvent mixture. The catheters were further dried for 30 minutes at 70° C. and exposed to UV-light having a wave length range between 200 and 300 nm. for 5 minutes.

[0090]Finally, sterilization of the coated catheter was performed while wetted with a solution of PVP using irradiation.

example 2

[0091]Preparation of a catheter having a crosslinked hydrophilic coating with unsaturated Poly(methyl vinyl ether / maleic anhydride) / hydroxyethylmethacrylate(HEMA) prepolymers.

[0092]20 parts of Gantrez® AN 119 was dissolved in 200 parts of acetone in a reaction vessel equipped with at stirrer. The reaction mixture was kept at room temperature. One drop of 1-methylimidazole was added to the solution as a catalyst. 5 mole % 2-hydroxyethylmethacrylate, based on contents of maleic anhydride were added dropwise to the stirred polymer solution during a period at 30 min. The mixture was stirred for further 2 hours at room temperature.

[0093]A 50:50 primer mixture with 5% solids was prepared by dissolving a medical grade polyurethane and the Poly(methyl vinyl ether / maleic anhydride) / HEMA unsaturated prepolymer in a 50:50 mixture of THF and acetone and was coated on PVC catheters as a primer by dipping in a manner known per se.

[0094]The catheters were dipped in the solution of poly(methyl viny...

example 3

[0098]A top coat and a primer solution were prepared as in Example b. To the solutions was added 1% by weight of the solid Darocure® 1173, a UV photo-initiator obtainable from Ciba Geigy.

[0099]PVC catheters were dipped in the primer solution, dried for 30 minutes and dipped in the top coat solution also containing 1% by weight of the solid of Darocure® 1173 and dried for further 30 minutes. Then, the coating was cross-linked by exposure to UV light.

[0100]The cross-linked coatings were then hydrolyzed and neutralized in a sodium hydrogen carbonate buffer solution for one hour before drying.

[0101]Then, sterilization of the coated catheter was carried out while wetted with a. solution of PVP using irradiation.

[0102]The friction tested according to the modified ASTM D 1894-93 method as described above showed a friction force of 0.02 when determined in water.

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Abstract

A method for sterilizing a medical device having a hydrophilic coating using radiation, said method including the steps of bringing the medical device having such coating in contact with an aqueous liquid for wetting the hydrophilic coating, said liquid including a solution of a hydrophilic polymer, and sterilizing the device by applying a sufficient amount of radiation to provide a coated device showing a significantly increased and prolonged water retention and lower friction coefficient when wet.

Description

RELATED APPLICATION[0001]This application is a Continuation-In-Part of the following two applications: PCT International Application No. PCT / DK99 / 00641, filed Nov. 19, 1999, which claims priority from and benefit of Danish Application No. PA 1998 01534, filed Nov. 20, 1998; and pending U.S. application Ser. No. 09 / 218,305, filed Dec. 22, 1998 now abandoned, which also claims priority from and benefit of the same Danish Application No. PA 1998 01534.FIELD OF THE INVENTION[0002]The present invention relates generally to sterilization of medical devices having hydrophilic coatings and more specific to sterilization using radiation. Furthermore, the invention relates to a sterilized set comprising a medical device provided with a hydrophilic coating and a liquid for wetting the hydrophilic coating, a method for protecting the hydrophilic coating of a medical device having such coating during sterilization using radiation as well as a medical device having a hydrophilic coating said medi...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61L2/00A61M5/00A61N5/00C08K3/00G21G5/00
CPCA61L2/087A61L2202/24
Inventor MADSEN, NIELS JORGEN
Owner COLOPLAST AS
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